Benign Gynecologic NeoplasmPhase 3NCT03009604
Does Simethicone Improve Operative Field in Gynecological Operations
A Phase 3 study testing Simethicone and Enema in people with Benign Gynecologic Neoplasm, run by Assiut University at 1 site in Egypt.
Trial summary
Mechanical bowel preparation aims to decrease the volume fecal content in the colon, which thereby decreases the total colony count of bacteria, thus, decreasing peritoneal contamination in case of bowel injury, improving the access to the surgical field and facilitating intraoperative bowel manipulation Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Benign Gynecologic Neoplasm
- What is being tested?
- Simethicone and Enema
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to May 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gynecological operations for benign conditions as hysterectomy, ovarian cystectomy and myomectomy.
Who cannot join
- History of allergic reaction to study drugs.
- More than one scar of previous operation.
- Suspicious of malignancy.
- Psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
Altayeb Mostafa, MBBCh contact
About this study
Mechanical bowel preparation aims to decrease the volume fecal content in the colon, which thereby decreases the total colony count of bacteria, thus, decreasing peritoneal contamination in case of bowel injury, improving the access to the surgical field and facilitating intraoperative bowel manipulation
- Conditions
- Benign Gynecologic Neoplasm
- Being tested
- Simethicone, Enema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimethiconeDrug
Simethicone 40mg oral tablets
EnemaDrug
sodium dihydrogen phosphate dihydrate 19.2 gram \& disodium hydrogen phosphate dodecahydrate 7.2 gram, in addition to purified water
| Study group | Role | What they receive |
|---|---|---|
| Simethicone | Experimental | women take 6 tablets (2 tablets after each meal) and to fast overnight before the operation Receives: Drug: Simethicone |
| Enema | Active comparator | women take 3 rectal Enema (8:00 pm, 12:00 am \& 8:00 am) and to fast over night before the operation. Receives: Drug: Enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
the degree of small & large bowel preparation
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionApr 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Gynecologic NeoplasmStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Altayeb Abd alal Mostafa Mohammad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009604
- Sponsor's protocol ID
- SIM
- Status last verified
- Jan 2017
- First submitted
- 2 Jan 2017
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Simethicone Improve Operative Field in Gynecological Operations
- ClinicalTrials.gov ID
- NCT03009604
- Acronym / sponsor ID
- SIM
- Conditions
- Benign Gynecologic Neoplasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mechanical bowel preparation aims to decrease the volume fecal content in the colon, which thereby decreases the total colony count of bacteria, thus, decreasing peritoneal contamination in case of bowel injury, improving the access to the surgical field and facilitating intraoperative bowel manipulation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simethicone | Experimental | Drug: Simethiconewomen take 6 tablets (2 tablets after each meal) and to fast overnight before the operation |
| Enema | Active comparator | Drug: Enemawomen take 3 rectal Enema (8:00 pm, 12:00 am \& 8:00 am) and to fast over night before the operation. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Gynecological operations for benign conditions as hysterectomy, ovarian cystectomy and myomectomy.
Key exclusion criteria (4 listed)
- History of allergic reaction to study drugs.
- More than one scar of previous operation.
- Suspicious of malignancy.
- Psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimethiconeSimethicone 40mg oral tablets | Drug | Simethicone |
| Enemasodium dihydrogen phosphate dihydrate 19.2 gram \& disodium hydrogen phosphate dodecahydrate 7.2 gram, in addition to purified water | Drug | Enema |
Primary outcome
the degree of small & large bowel preparation
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Altayeb Mostafa, MBBCh contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Simethicone and Enema in people with Benign Gynecologic Neoplasm, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Altayeb Mostafa, MBBCh (00201003722811), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the degree of small & large bowel preparation (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.